Sterile “cleanroom” environments demand that any person or item entering the room be free of a certain level of contaminants. Sterilized environments are most commonly designed for use in manufacturing facilities and medical research and treatment facilities in the pharmaceutical, biotechnology, and healthcare industries, to name a few. Sterile cleanroom environments may be classified under a variety of classification schemes, including the International Organization of Standardization (“ISO”) Cleanroom Standards, whereby the highest level of sterilization is an ISO 1 cleanroom, and normal ambient air (no sterilization) is classified as ISO 9.
A variety of products are required to enter cleanroom environments, including paper and paper products used to document manufacturing and testing records within the controlled areas. Such paper products include, but are not limited to, forms, logbooks, tags and batch records. All of these documents are necessary to detail the manufacturing and testing processes so as to ensure that proper procedures are followed and results are documented. Indeed, these documents are subject to review by regulatory agencies, such as the U.S. Food and Drug Administration, and represent the mechanism by which such agencies can review the manufacturing and testing process details after the manufacture, testing, or handling of a drug product, for example, to assure patient safety.
However, paper and paper products are a significant contamination source due to shedding fibers, particulates and microorganisms (e.g., bacillus and mold). About 40% of paper products used in sterile environments are standard documents that can be pre-printed, packaged and sterilized by known means. However, the remainder of the documents introduced into sterile environments cannot be pre-printed, sterilized and packaged in a timely fashion. Their preparation requires information that is not readily available until days, or even hours, before the manufacturing or testing is to begin. In some instances, they must be prepared while manufacturing and/or testing is underway. Because of this, these documents are forced to be brought to sterilized areas without prior treatment for the reduction of shedding fibers, particulates and microorganisms. Thus, they represent a significant contamination source.
One solution in the industry is to pre-package products that must be introduced into a cleanroom environment. As disclosed in U.S. Pat. Nos. 6,123,900, 6,607,698 and 6,333,006, chemical containers are first pre-sterilized according to the methods set forth therein, and then the containers are enclosed within a first and second layer, and then placed into a carton having a liner. To unpackage, the container (with the two sealed layers and the liner) is removed from the carton on the loading dock. Once transported to a first sterile environment, the liner is removed and the container (now enclosed by two sealed layers) is placed on a shelf for future use. Once it is ready to be used, the second sealing layer is removed and the container (now enclosed by one sealed layer) is moved to a higher-grade sterile environment. In practice, that method requires that the outside of the liner and each sealing layer be sprayed with antiseptic and/or antibacterial sanitizers to remove any contaminants, such as bacteria and mold, before being transported to the next (more sterile) environment. Such an additional step causes vapors from the sanitizing agent to fill the atmosphere of the cleanroom, which introduces particles into the clean room and can be dangerous to the cleanroom operation as well as the workers. Additionally, according to this method, the product is removed from the last layer before it is transported to the final cleanroom where it is to be utilized.
To solve this problem, the invention provides for a method of packaging sterilized products by enclosing them in four successively sealed layers so as to ensure their sterility. Further, the invention provides a method of introducing packaged sterilized products, specifically paper products, into a sterile environment.